US Specialty Formulations, a rapidly growing pharmaceutical manufacturer centrally located in the Lehigh Valley, Pennsylvania, has an opportunity for a highly motivated individual to join our team as Quality Control Manager. The Quality Control Manager will direct the overall operations of the Quality Control Laboratory and lead and develop the Quality Control team. This position is responsible for implementing and managing cGMP compliant practices in the laboratory environment and managing raw material and component testing , analytical methods transfer, and in-process and finished product release and stability testing. Experience with analytical instruments, such as HPLC, UV-VIS, IR, Auto Titrator, is required. Hands on experience with analytical method development and validation is necessary. Thorough understanding of cGMPs, 21 CFR 210-211, and other industry regulations is required. Excellent organizational skills and the ability to make and meet goals in an effective and efficient manner are essential.
- Manage the day-to-day operations of analytical QC laboratory in a high-growth, fast-paced work environment while ensuring compliance with cGMP / cGLP guidelines and corporate SOPs.
- Oversee the qualification of new equipment and the ongoing re-qualification of existing equipment.
- Manage the laboratory equipment qualification, calibration, and preventative maintenance programs.
- Lead method development, assay validation and characterization for multiple drug substances.
- Develop and manage a team of 2-5 quality control technicians and ensure all personnel are appropriately trained and qualified to perform activity relevant to their positions.
- Work with outside departments to manage timelines and ensure projects milestones are met.
- Develop, implement, and maintain processes and procedures in compliance with cGMP and cGLP guidelines.
- Write SOPs, technical reports, and protocols necessary for QC laboratory operations.
- Interact with Regulatory Authorities during inspections and provide input to responses to Health Authorities.
- Lead laboratory investigations to ensure timely resolution of any issues.
- PhD or MS in Chemistry, Biochemistry, or related field
- Minimum of 8-10 years of experience in the pharmaceutical industry or other highly regulated industry
- Minimum of 3 years in a supervisory or managerial role
- Thorough knowledge of cGMPs and cGLPs and their applications
- In depth understanding of wet chemistry and instrumental analysis
- Ability to troubleshoot analytical methodologies and instrumentation
- Expertise in HPLC operation and analysis
- Experience in analytical method development and validation
- Expert ability in scientific and technical writing, with experience writing SOPs, technical reports, IQ/OQ/PQs, and validation protocols
- Proficiency with computer office tools (Word, Excel, Outlook, etc.)
- Organizational skills